Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

Boston Scientific

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839396

CDM00049710/90876693 (Other Identifier)

G120075

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Full description

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

GUIDE XT may be used for planning of programming as needed.

Enrollment: 313 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
• Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

• Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
• Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
• Any other active implanted devices including neurostimulators and /or drug delivery pumps
• Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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313 participants in 2 patient groups

Medium continuous dose of stimulation

Active Comparator group

Description:

Subjects in this arm will receive stimulation settings at a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.

Treatment:

Device: Deep Brain Stimulation

Low intermittent dose of stimulation

Sham Comparator group

Description:

Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.

Treatment:

Device: Deep Brain Stimulation